Animal NDC 72483-200-05 Alfa Veterinary 5% Dextrose
5% Dextrose

Animal Product Information

Field Name Field Value
Animal NDC Code 72483-200-05
Proprietary Name Alfa Veterinary 5% Dextrose What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name 5% Dextrose What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Laboratorios Alfa Srl
Product Type Prescription Animal Drug
Usage Information
    5% dextrose solution is indicated as a source of water and calories. It is used to decrease the excessive pressure of spinal brain fluid, also as sclerosing to treat varicose veins and decrease intracranial pressure
Active Ingredient(s)
  • Dextrose Monohydrate
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • WATER (059QF0KO0R)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Alfa Veterinary 5% Dextrose Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



5% dextrose solution is sterile, non-pyrogenic for fluid and calorie replacement, and is supplied in single-dose containers for intravenous administration. Discard the unused portion. Does not contain antimicrobial agents.

Chemically, dextrose (glucose) is a monosaccharide containing an aldehyde group (an aldose). In water it exists primarily as a six membered hemi-acetal ring in equilibrium with a minor amount of the free aldehyde form and a five membered hemiacetal form. Dextrose used is either an anhydrous or monohydrate form.

The Plastic container, a semi-rigid bottle, is made of a low-density polyethylene which is a flexible and resistant material. No venting is necessary during infusion.

 Table 1. Veterinary 5% Dextrose Injection, USP
 Size (mL)     Composition
    (g/100 mL)
        *Osmolarity
        (mOsmol/L)
        (Calculated) 
pH   Caloric Content (kcal/L)
    Dextrose 1H2
 100          5.5               278         3.2-6.5                 170   
 250
 500
 1000

No venting is necessary during infusion.


Clinical Pharmacology



Veterinary 5% Dextrose Injection, USP solution has value as a source of water and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

Glucose is a nutrient of the first order, provides 4.1 Kcal per gram and like all carbohydrates has the property of decreasing protein catabolism


Indications And Usage



5% dextrose solution is indicated as a source of water and calories. It is used to decrease the excessive pressure of spinal brain fluid, also as sclerosing to treat varicose veins and decrease intracranial pressure


Warning



Veterinary 5% Dextrose Injection, USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudo agglutination or hemolysis.

The intravenous administration of 5% Dextrose Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, over hydration, congested states, or pulmonary edema.

The risk of dilutive states is inversely proportional to the electrolyte concentrations of the injections.

The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

Excessive administration of dextrose injections may result in significant hypokalemia.

The container label for these injections bears the statement: Do not administer simultaneously with blood.
Keep out of the reach of children.


Adverse Reactions



Reactions which may occur because of the injection or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.


Precautions



Veterinary 5% Dextrose Injection, USP should be used with caution in patients with known overt or subclinical diabetes mellitus.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

This is a hypotonic solution and as such should not be used for resuscitation.

Do not administer unless solution is clear and both seal and container are intact.


Dosage And Administration



As directed by a veterinarian. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with veterinarian, if available. If, in the informed judgment of the veterinarian, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced.

Do not store solutions containing additives. Discard unused portion.


Overdosage



In an event of over hydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See Warnings, Precautions, and Adverse Reactions.


Storage



Store below 30°C (86°F).


Precaution For Use Of The Bottle



This is a single dose container and does not contain preservatives.

Use the solution immediately after the bottle is opened, discard the remaining one.
Squeeze and inspect the bottle, discard if leaks are found or if the solution contains visible and solid particles.

Do not administer simultaneously with blood.
Do not use it unless solution is clear, and seal is intact.

DIRECTIONS FOR USE PLASTIC CONTAINER:

This is a single dose container and does not contain preservatives. If leaks are found, discard solution as sterility may be impaired. Use the solution immediately after the bottle is opened, discard the remaining one. Discard unused portion. If supplemental medication is desired follow directions below:

Preparation and administration
1. Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired.
2. Suspend container from eyelet support.
3. Remove Plastic protector from ports area at the bottom of container.
4. Hold the bottle in vertical position and inset pyrogen free IV administration set in the outlet port. Use aseptic Technique

To add medication
WARNING: Additives may be incompatible.
To add medication before solution administration
1. Prepare medication site.
2. Using syringe with 19 to 22 gauge needle, puncture inlet port and inject.
3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration
1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 18 to 21 gauge needle, puncture inlet port and inject.
4. Remove container from IV pole and/or turn to an upright position.
5. Mix solution and medication thoroughly.
6. Return container to in use position and continue administration.

CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.


Package Insert



For Animal Use Only


Package Label.Principal Display Panel



Veterinary 5% Dextrose Injection,

NDC: :72483-200-10 1000 mL 5% Dextrose

NDC: 72483-200-05 500 mL 5% Dextrose

NDC: 72483-200-25 250 mL 5% Dextrose

NDC: 72483-200-01 100 mL 5% Dextrose


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.